A new oral testosterone (TLANDO) treatment regimen without dose titration requirement for male hypogonadism.

ABSTRACT:

Background

Male hypogonadism (testosterone level < 300 ng/dl) is a clinical syndrome that results from failure of the testis to produce physiological levels of testosterone. Most marketed testosterone replacement therapy products often require multiple dose adjustment clinic visits to achieve the desired, eugonadal testosterone levels.

Objective

To evaluate the efficacy and safety of a novel oral testosterone undecanoate therapy for the treatment of hypogonadism.

Material and methods

Ninety-five (N = 95) hypogonadal men were enrolled in this open-label, single-arm, multicenter study in the United States (NCT03242590). Subjects received 225 mg of oral testosterone undecanoate (TLANDO) twice a day for 24 days without dose adjustment. Primary efficacy was percentages of

SUBMITTER: DelConte A 

PROVIDER: S-EPMC9304136 | biostudies-literature | 2022 May

REPOSITORIES: biostudies-literature